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Bacterial Endotoxins
Aqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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Cartridge Code
Code M (2-118) O-rings
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Cartridge Nominal Length
4 in. (10 cm)
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Catalogue Number
CP15M4S03
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Chemistry
Borosilicate Glass Fiber (BGF)
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Device Configuration
Cartridge
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Device Material
Polypropylene
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Device Size
4 in.
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Diameter
7.4 cm (2.9 in.)
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Filter Grade
AP15
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Filtration Area
0.16 m²
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Format
Single Layer
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Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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Gravimetric Extractables
The extractables level was equal to or less than 100 mg per 4-inch cartridge after 24 hours in water at controlled room temperature.
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Length
4 in. (10 cm)
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Material Package
Double Easy-Open bag
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Material Size
3
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Maximum Differential Pressure, bar (psid)
3.5 bar (50 psid) @ 25 °C
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Maximum Inlet Pressure, bar (psi)
3.5 bar (50 psi) @ 25 °C
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Media
Lifegard™
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Nominal Pore Size
1.0 µm
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Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
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Pore Size
1.0 µm
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Sanitization
30 min with hot water @ 80 °C
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Seal Material
Silicone (SI)
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Sterilization
10 autoclave cycles or SIP @ 121 °C for 30 min
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Support Material
Polypropylene
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Trade Name
Lifegard™
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USP Bacterial Endotoxins
A sample aqueous extraction contains less than 1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
+852-3069 6950
css@gugent.com.hk
